UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044360
Receipt number R000050661
Scientific Title Effects of home-exercise programs on hip pain and function in patients with hip osteoarthritis: a randomized controlled trial
Date of disclosure of the study information 2021/06/01
Last modified on 2023/05/30 10:24:03

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Basic information

Public title

Effects of home-exercise programs on hip pain and function in patients with hip osteoarthritis

Acronym

Effects of home-exercise programs in patients with hip osteoarthritis

Scientific Title

Effects of home-exercise programs on hip pain and function in patients with hip osteoarthritis: a randomized controlled trial

Scientific Title:Acronym

Effects of home-exercise programs in patients with hip osteoarthritis

Region

Japan


Condition

Condition

Osteoarthritis of hip

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine the effects of low-intensity vibration vs foam rolling on pain and functional recovery in patients with hip osteoarthritis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Hip pain

Key secondary outcomes

hip function
motor function
physical activity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Interventions/low-intensity vibration
Low-intensity vibration is applied at a frequency of 50 Hz for 2 min * 3 positions/day for 1 month

Interventions/Control_2

Interventions/foam rolling
Foam rolling is applied for 2 min * 3 positions/day for 1 month

Interventions/Control_3

Control/exercise
Hip muscle training is applied for 2 min * 3 programs/day for 1 month

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

patients with hip osteoarthritis

Key exclusion criteria

normal hip
acetabular dysplasia
severe hip OA
rheumatoid arthritis
femoral head necrosis
ipsilateral hip surgery
total hip arthroplasty
neurological impairment cardiovascular disease
severe knee OA
severe cognitive impairment
pain around the hip joint for less than 3 months
hip pain intensity of 40 or lower on a 100-mm visual analog scale

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hisashi
Middle name
Last name Ikutomo

Organization

Masuhara Clinic

Division name

Department of Rehabilitation

Zip code

530-0042

Address

3-4-2

TEL

0663580200

Email

hisashiikutomo@gmail.com


Public contact

Name of contact person

1st name Hisashi
Middle name
Last name Ikutomo

Organization

Mauhara Clinic

Division name

Department of Rehabilitation

Zip code

530-0042

Address

3-4-2

TEL

0663580200

Homepage URL


Email

hisashiikutomo@gmail.com


Sponsor or person

Institute

Masuhara Clinic

Institute

Department

Personal name



Funding Source

Organization

Dream factory incorprated

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Niigata University of Health and Welfare

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University of Health and Welfare

Address

1398, shimamimati, kita-ku, niigata city, Niigata

Tel

025-257-4455

Email

rinri@nuhw.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

医療法人 増原クリニック(大阪府)


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 05 Month 28 Day

Date of IRB

2021 Year 06 Month 30 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2023 Year 06 Month 01 Day

Date of closure to data entry

2023 Year 09 Month 01 Day

Date trial data considered complete

2023 Year 09 Month 30 Day

Date analysis concluded

2023 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2021 Year 05 Month 28 Day

Last modified on

2023 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050661


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name